The main objectives of the study are to demonstrate the non-inferiority of the immune response induced by co administered GBS-NN/NN2 and tetanus, diphtheria, and acellular pertussis (Tdap) compared to the separate administration of GBS-NN/NN2 and Tdap, to evaluate the reactogenicity of GBS NN/NN2 when administered alone or in combination with Tdap, and to evaluate the safety of GBS-NN/NN2 when administered alone or in combination with Tdap in terms of serious adverse events (SAEs) and unsolicited adverse events (AEs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
564
Intramuscular injection.
Intramuscular injection.
Intramuscular injection.
Number of Participants Expressing Anti-tetanus Toxoid Antibody Concentration ≥0.1 IU/mL
Time frame: Day 85
Number of Participants Expressing Anti-diphtheria Toxoid Antibody Concentrations ≥0.1 IU/mL
Time frame: Day 85
Number of Participants Expressing Anti-pertussis Toxin Antibodies
Time frame: Day 85
Number of Participants Expressing Anti-filamentous Hemagglutinin (FHA) Antibodies
Time frame: Day 85
Number of Participants Expressing Anti-pertactin (PRN) Antibodies
Time frame: Day 85
Number of Participants Expressing RibN Antibody
Time frame: Day 85
Number of Participants Expressing Alp1N Antibody
Time frame: Day 85
Number of Participants Expressing Alp2N Antibody
Time frame: Day 85
Number of Participants Expressing AlpCN Antibody
Time frame: Day 85
Number of Participants Experiencing Solicited Local Adverse Events (AEs)
Time frame: Day 63
Number of Participants Experiencing Solicited Systemic AEs
Time frame: Day 63
Number of Participants Experiencing Unsolicited AEs
Time frame: Day 85
Number of Participants Experiencing SAEs
An SAE is any occurrence that results in death, poses a life-threatening situation, necessitates inpatient hospitalization or the extension of an existing hospital stay, leads to persistent or significant disability or incapacity, involves a congenital anomaly or birth defect, or is considered an important medical event that, while not resulting in death, being life-threatening, or requiring hospitalization, still warrants serious concern.
Time frame: Day 85
Number of Participants Experiencing Medically-attended Adverse Events (MAAEs)
A MAAE is defined as an AE that leads to an unscheduled visit to a health care professional.
Time frame: Day 85
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